Positive top-line results were announced for a Phase 3 study of CAM2038 for the treatment of moderate-to-severe Chronic Low Back Pain (CLBP) in patients previously on long-term daily opioid therapy. The study met its primary efficacy endpoint of Average Pain Intensity (API), demonstrating that patients with CLBP receiving treatment with CAM2038 experienced a statistically significant reduction in pain compared with placebo. Furthermore, the key secondary endpoint of Worst Pain Intensity also demonstrated statistical significance.
The investigational drug CAM2038 (buprenorphine), currently under review is a buprenorphine weekly and monthly subcutaneous depot injection for the treatment of moderate to severe opioid use disorder, as a part of a comprehensive treatment plan to include counseling and psychosocial support. The product is designed for individualized treatment from initiation and stabilization to longer-term maintenance therapy.
The preliminary findings come from the multicenter, double-blind, randomized withdrawal, placebo-controlled Phase 3 HS-16-555 trial(N=340), which enrolled patients who had been treated with opioids for moderate-to-severe CLBP for a minimum of 3 months prior to trial screening. The patients were randomized to receive CAM2038 50mg/mL once weekly at doses of 8mg, 12mg, 16mg, 24mg, or 32mg; CAM2038 356mg/mL once monthly at doses of 64mg, 96mg, or 128mg; or placebo.
The primary endpoint of change in Average Pain Intensity (API) from baseline to week 12 was achieved by the CAM2038 group, who experienced a statistically significant reduction in pain vs the placebo group. A secondary endpoint of Worst Pain Intensity (WPI) was also statistically significantly reduced in the treatment group compared to placebo at week 12.
The safety profile observed with CAM2038 was favorable and consistent with previous studies with CAM2038 as well as the known safety profile of buprenorphine.
CAM2038 provides a slow release of the drug over time, through a proprietary technology known as FluidCrystal®, and is presented ready for use in prefilled syringes for weekly or monthly administration by a healthcare professional.
The next generation proprietary FluidCrystal® Injection Depot Technology used in the subcutaneous injection of CAM2038 includes a lipid-based liquid with a dissolved active ingredient. Upon injection and contact with fluids in the tissue, the lipid solution transforms into a crystalline gel, which encapsulates the active ingredient, allowing for a slow release of the drug over time.
The long-term safety of CAM2038 is being evaluated in a 52-week open-label extension study, in which patients are either continuing from the randomized efficacy portion of the study or were enrolled directly in the open-label extension study phase.
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